NCT06210971 Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
| NCT ID | NCT06210971 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
Eligibility Criteria
Inclusion Criteria: * Age: 18\~75 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1. * Histopathologically confirmed rectal adenocarcinoma. * The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge. * Clinical stage: T3-4NanyM0 or T1-2N+M0. * Adequate bone marrow function as evidenced by: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count ≥100×10\^9/L, Hemoglobin (Hb) ≥90 g/L. * Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, Serum albumin ≥3 g/dL. * Adequate renal function as evidenced by: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. * Be willing to undergo UGT1A1 gene testing and UGT1A1 genotype of \*1\*1 or \*1\*28. * Accept the neoadjuvant chemoradiotherapy protocol of this study and sign the informed consent. Exclusion Criteria: * Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc. * Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment. * Active HIV infection. * Combined with uncontrollable systemic diseases. * History of allergy or hypersensitivity to drug or any of their excipients. * Any clinical indicators indicating contraindications to radiotherapy/chemotherapy and surgery. * Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. * Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception. * Patients with poor cognitive abilities who are unable to answer questions, fill out questionnaires, or have mental disorders. * Patients who do not meet the inclusion criteria; patients who meet the inclusion criteria but are not suitable to participate in this trial judged by the investigator.
Contact & Investigator
Fengpeng Wu, Professor
PRINCIPAL INVESTIGATOR
Hebei Medical University Fourth Hospital
Frequently Asked Questions
Who can join the NCT06210971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06210971 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06210971 currently recruiting?
Yes, NCT06210971 is actively recruiting participants. Contact the research team at drxiaolinlin@163.com for enrollment information.
Where is the NCT06210971 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT06210971 clinical trial?
NCT06210971 is sponsored by Hebei Medical University Fourth Hospital. The principal investigator is Fengpeng Wu, Professor at Hebei Medical University Fourth Hospital. The trial plans to enroll 60 participants.
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